NICHI-IKO PHARMACEUTICAL 2012 Nichi-Iko Pharmaceutical Co., Ltd. 1-6-21 Sogawa, Toyama-shi, Toyama Prefecture, Japan 930-8583 TEL: +81-76-432-2121 FAX: +81-76-443-1666 http://www.nichiiko.co.jp/ Top Management Perspective P2 The sixth Medium-term Business Plan P3 Generic Pharmaceuticals Japan in to Become Striving one 4 P World’s Top-10 P6 of the Sharing & Product Information Creation Tomorrow for Maintaining Close Contact with Medical Professionals P8 Providing the Information Users Want and Need Responsive Operating Systems P10 More Promise ultra-highQuality Our to State-of-the-Art Production Facilities with a Commitment to ultra-high quality P12 Becoming the Most Valued Partner for Medical Care Professionals P13 P9 Top Management Perspective The sixth Medium-term Business Plan "Pyramid" for four years from April 2012 to March 2016 While fulfilling our mission of providing a stable supply of low-cost, ultra-high quality generic pharmaceuticals, we seek to become a global company operating throughout the international marketplace. 1 Policy Mission Statement We, Nichi-Iko, provide value-added, ultra-high quality generic products that meet various requirements from patients, doctors, pharmacists, wholesalers and pharmaceutical companies in the global market as one of the most respected, well established generic companies in the world. The Nichi-Iko Group will rebuild its organizational power to achieve its vision of "Challenge the global market” to become one of the top 10 generic pharmaceutical companies in the world and based on its organizational power, it will implement the four strategies it has announced. Since its founding in 1965, Nichi-Iko Pharmaceutical Co., Ltd. has continued to These four strategies will complement one another to bring the company to a higher manufacture and market highly economical, high-quality ethical drugs in its efforts to help people level of performance as it carries out action plans based on the strategies, and we lead healthy lives. compare this process to the shape of a "pyramid." Thus we will create a robust and stable corporate structure. Although our core business is generics, we also sell such new drugs as Sedapain Inj. 15, an antagonist analgesic we developed independently, and Unicon Tablets, a sustained-release theophylline imported from overseas. We are capitalizing on our extensive experience in creating new drugs as we pursue development of new generic pharmaceuticals. Today, our products are used in medical institutions throughout Japan. In 1980, we became the first generic pharmaceuticals maker to list its shares on the Second Section of the Nagoya Stock Exchange and, in 1981, the first to achieve listing on the Second Section of the Osaka Securities Exchange. We were promoted to the First Section of both exchanges in November 2006. In December 2010, our shares were listed on the First Section of the Tokyo Stock Exchange. In recent years, coping with health-care expenses has become a crucial challenge for Japan. Widespread use of low-cost generic pharmaceuticals is being promoted as one measure to meet this need. In April 2006, Japan’s prescription format was changed to promote the use of generic pharmaceuticals, with a resulting expansion of the generics market, which comprises mainly dispensing pharmacies. Against this background, Nichi-Iko adopted “Generics for your prime choice” as its corporate slogan and began implementing a range of measures to create demand for Japanese 2 Four strategies Brand strategy Cost strategy To become an indispensable manufacturer of generics by continuing to provide customers worldwide with unique and satisfactory products and services that can only be offered by Nichi-Iko. To improve its cost management methods in order to continue generating profits. To create corporate value by working together closely within whole organization •Creation of bigger generic market •Contribution to society •Gaining the trust of customers and shareholders (through stable supply, ultra-high quality, and commitments) •Greater recognition and presence of Nichi-Iko as a manufacturer of generics The sixth Medium-term Business Plan To challenge to continue generating profits •Making all-out efforts for cost management from active pharmaceutical ingredients to all other materials and methods used during manufacturing process. •Establishment and implementation of cost management systems •Stepping up efforts to use management accounting for decision-making •Increasing productivity •“Selection and concentration” on product items and production sites including overseas sites. Challenge the global market with creation power Vision To become one of the top 10 generic pharmaceutical companies in the world. generic pharmaceuticals — whose rate of diffusion lags behind that of European and U.S. brands — among patients, medical professionals such as doctors and pharmacists, wholesalers and pharmaceutical companies around the world. Intent on strengthening our leadership position in the global generics market, moreover, we are accelerating expansion of our operations through strategic alliances with foreign companies. In June 2010, we established sanofi-aventis Nichi-Iko K.K. in a joint venture with sanofi-aventis Group, a leading French pharmaceuticals maker. We followed this move in July 2010 by concluding an exclusive distributorship agreement with the Swiss-based distribution and marketing company DKSH Group and in October 2010 by creating a capital and business alliance with Aprogen Inc., a Korean bio-venture company. With the environment surrounding the ethical drug market continuing to undergo dramatic change, we will remain committed to fulfilling our social mission by providing a stable supply of low-cost, reliable generic drugs of ultra-high quality, and to conduct business as a global company that challenges growth in the world marketplace. Customer-friendly strategy Differentiation strategy To provide products and services that meet customer requests and identify customer requests so that Nichi-Iko can continuously improve Nichi-Iko’s products and services. To encourage all employees to seek the value which Nichi-Iko can offer to customers in order to enhance its competitiveness. To take actions to meet customers’ demand with integrity and sincere efforts •Improving the ability to handle complaints •Approach to medical institutions with defined goals (DPC Hospitals (Diagnosis Procedure Combination), dispensing pharmacies, and group hospitals) •Making Nichi-Iko’s presence more among the special agencies and wholesalers •Reinforcement of specialized human resources Cost strategy Brand strategy Differentiation strategy Customer-friendly strategy F cor ound po at rat ion e c of ult ure izat an Org r owe lp iona To meet customers demand with Nichi-Iko’s products •Development of anticancer drugs •Development of biosimilars •Provision of “ultra-high quality” products at reasonable price •Provision of products and services needed by customers •Development of value –added pharmaceuticals •Strengthening intellectual property management •Offering additional information needed by customers President and CEO Yuichi Tamura 3 Major numerical targets Item Net sales 2 Corporate Brochure 2012 Nichi-Iko Pharmaceutical Co., Ltd. Term to March 2013 (Millions of yen) Term to March 2014 Term to March 2015 Term to March 2016 92,500 103,000 115,000 130,000 Operating income 8,300 9,000 11,500 14,300 Ordinary income 8,000 8,800 11,100 14,000 Nichi-Iko Pharmaceutical Co., Ltd. Corporate Brochure 2012 3 Generic Pharmaceuticals Japan in Energizing the Generics Market with an Eye to Strong Growth Revision of medical treatment fees (Additional medication Phase-out of adjustment history management fee coefficient for DPC under GE system) Promoting use of generic names, formulations, etc., in writing prescriptions Revision of medical treatment fees Re-revision of Additional fee for GE dispensing GE dispensing ratio changed from prescription to volume basis prescription formats Partial expansion of substitution by generics The enactment in the United States of the Drug Price Competition and Patent Term Restoration Act of 1984 significantly eased regulatory constraints on the manufacture and sale of generic drugs. Today, generics account for some 60 to 70% of unit sales Efficiency enhancement program Target of 30% GE share set by Ministry of Health, Labor and Welfare of all ethical drugs in countries such as United States, the United Kingdom and Germany, which are advanced markets in terms of generic pharmaceuticals usage. In Japan, where the government has set a target of “increasing generic drugs’ share by volume to over 30% by fiscal 2012,” various measures have been implemented to promote their use. Notification (Upgrading of drug indications) Since the market share generic pharmaceuticals continues to remain virtually flat, however, hovering near the 20% level, Change in health-care management regulations more forceful measures are anticipated. As the generic market expanded, Nichi-Iko has formulated the sixth Medium-term Business Plan “Pyramid” for four years from April 2012 to March 2016, Notification (Supply stability) and aims to become one of the top10 generic pharmaceutical companies in the world. Notification (Use of generic names in place of brand names) Revision of medical treatment fees (GE incentive) Implementation of DPC at special function hospitals Adoption of GE by the Ministry of Education, Culture, Sports, Science and Technology Government Action Timeline Recommendation by the Ministry of Internal Affairs and Communications Action Program Revision of medical treatment fees (Prescriptions permitting substitution of generics) Notification (Information provision) Revision of medical treatment fees Adoption of GE by national hospitals Promotion of widespread generics use under National Health Insurance system Government statement (Permission for dispensing generics) 30.0% Notification (Improvement in reliability) Notification (Compliance with standards) New vision of the pharmaceutical industry Revision of medical treatment fees Prescriptions that do not allow substitution by generics GE dispensing ratio 30% (prescription basis) Not announced Figures published by the Japan Generic Medicines Association (JGA) 16.4% 16.8% 17.1% 16.9% 17.2% 17.6% Nihon Iyakuhin Kogyo Co., Ltd. established. Nichi-Iko Milestones Shares listed on Second Section of Osaka Securities Exchange. 4 Corporate Brochure 2012 Not announced 12.2% 11,477 12,506 265 629 2000 2001 14,662 1,267 2002 MPS (Medical Practice Support) Team established. Shares listed on Second Section of Nagoya Stock Exchange. Nichi-Iko Pharmaceutical Co., Ltd. 64,352 54,806 42,841 24,299 1965 1980 1981 1999 23.0% 77,740 Nichi-Iko’s ordinary income (millions of yen) 10.8% Ministry of Health, Labor and Welfare target by March 2013 20.3% Pharmaceutical industry vision Nichi-Iko’s net sales (millions of yen) Notification of differences in drug costs to the insured Publication of list of national hospitals adopting GE Synthetic penicillin PENGOOD launched as branded generic drug. 17,646 18,296 2,345 2,532 2003 2004 Nichi-Iko Distribution Center completed in Yasuda, Namerikawa-shi, Toyama Prefecture. 2,508 2005 Merger completed with Nihon-Gallen Co., Ltd. Maruko Pharmaceutical Co., Ltd. made subsidiary through stock acquisition. Company name changed to Nichi-Iko Phamaceutical Co., Ltd. 29,254 3,472 2006 32,328 4,473 2007 5,442 2008 6,121 2009 6,883 7,309 2010 2011 2012 East Japan Distribution Maruko Pharmaceutical Center completed in Kuki-shi, Co., Ltd. made a wholly Saitama Prefecture. owned subsidiary. West Japan Distribution Center completed in Kobe, Hyogo Prefecture. 5th Medium-Term Business sanofi-aventis Nichi-Iko Plan, “Honeycomb 2012,” K.K. established through announced. joint venture. Establishment of Nichi-Iko Medical Practice Institute Co., Ltd. Announcement of the sixth Medium-term Business Plan “Pyramid” Share listings upgraded to the First Sections of both Osaka Securities Exchange and Nagoya Stock Exchange. Teikoku Medix Co., Ltd. made a subsidiary through stock acquisition. Nichi-Iko Pharma Factory Co., Ltd. launched. Completion of the “Honeycomb Building,” global development and quality control center. Yakuhan Pharmaceutical Co., Ltd. made a subsidiary through stock acquisition. Shares listed on the First Section of Tokyo Stock Exchange. Nichi-Iko Pharmaceutical Co., Ltd. The accounting period was changed from November 30 to March 31. Corporate Brochure 2012 5 to Become Striving one World’s Top-10 of the To become one of the top 10 generic pharmaceutical companies in the world Nichi-Iko is pursuing strategic alliances with overseas companies in its efforts to reinforce its earnings and manufacturing base to achieve its vision and goal of challenging growth in the global marketplace. In June 2010, we established sanofi-aventis Nichi-Iko K.K. in a joint venture with sanofi-aventis Group, a leading French pharmaceuticals maker. We followed this move in July 2010 by concluding an exclusive distributorship agreement with the Swiss-based distribution and marketing company DKSH Group and in October 2010 by creating a capital and business alliance with Aprogen Inc., a Korean bio-venture company. Joint press conference on May 28, 2010 6 Establishment of sanofi-aventis Nichi-Iko K. K. Full agency agreement with Swissbased DKSH Group signed Conclusion of a capital and business alliance with Aprogen Inc. of Korea Listed on the First Section of the TSE Completion of the “Honeycomb Building,” a global development and quality control center We conducted joint capital investment with sanofi-aventis Group (SA), a leading French pharmaceuticals company, to establish sanofi-aventis Nichi-Iko K.K. in June 2010. This partnership will keep enhancing our competitiveness by creating synergies between Sanofi’s global resources and our generics business. We entered into agency agreement with DKSH Group for handling of our generics in Thailand, Malaysia and Hong Kong. Headquartered in Switzerland, DKSH provides companies seeking to expand their markets, primarily in Asia, with a comprehensive service package that covers the range from procurement, research and analysis to marketing, sales, distribution and logistics. We formed a capital and business alliance with Aprogen Inc., a bio-venture company based in Daejeon, South Korea, for joint R&D in the biosimilar business, which is expected to experience market growth in the future. Aprogen owns a number of technologies and patents for development systems for highly expressive biomedicines. Its innovative technologies are receiving attention for their contribution to reducing development and manufacturing costs — a particular challenge facing biosimilar makers. On December 1, 2010, Nichi-Iko listed its shares on the First Section of the Tokyo Stock Exchange. In addition, in December 2011, the Company was delisted from the Osaka and Nagoya Stock Exchanges mainly to reduce costs incurred by double listing. Thus the trading of its shares was unified so that they are all traded at TSE’s First Section. In October 2011, the Company completed the “Honeycomb Building,” a global development and quality control center, within its Namerikawa Plant. As a symbol of the company’s efforts to challenge the world market, this facility is responsible for development and quality control, and together with the Pentagon and Nexstage Buildings, both of which are already in operation, it enables the Nichi-Iko Group to produce “ultra-high quality” generic pharmaceuticals in accordance with its quality policy. Corporate Brochure 2012 Nichi-Iko Pharmaceutical Co., Ltd. Conclusion of a comprehensive agreement with sanofi-aventis K.K. to jointly promote generic pharmaceuticals In November 2011, the Company entered into a comprehensive agreement with sanofi-aventis K.K., headquartered in Tokyo’s Shinjuku Ward, to jointly promote its products with the aim of maximizing product value at the generics market and further popularizing generics. Nichi-Iko Pharmaceutical Co., Ltd. Corporate Brochure 2012 7 Sharing & Product Information Creation Tomorrow for Maintaining Close Contact with Medical Professionals Providing the Information Users Want and Need Close contact with medical professionals We redesigned the product information search page on our Web site and expanded the content, making it one of The “Stu-GE” page on Nichi-Iko’s corporate Web site, a rich source of information and tools related to the generics the most extensive information provision systems available. In addition to upgrading our Web site, we established the market and medical treatment, is designed to provide the public with information concerning generic pharmaceuticals and Customer Support Center in order to support our products by enhancing our ability to respond flexibly to inquiries medical treatment administration. We also deploy MRs nationwide to ensure continuous information dissemination and concerning product quality and safety and to requests for information materials from patients using our medicines. maintain full awareness of the products we market among health-care professionals. Stu-GE The “Stu-GE” page on Nichi-Iko’s corporate Web site provides the public with information concerning generic pharmaceuticals and medical treatment. As the name “Stu-GE” (coined from “study generics”) implies, this page answers various questions concerning generics and medical treatment administration. Video transmission of information about generics and medical treatment Video and audio media serve as efficient tools for clarifying issues concerning generics and medical systems. Nichi-Iko Web site content enhancement MPS data compilation Posting of data compiled by NichiIko MPS. MPS diary Presents observations and thoughts arising during the data compilation and information submission processes in blog format. Posting of detailed Useful tools descriptions of journals Sales promotion tools and books containing and health-care support literature on generics. tools designed to deepen Information concerning understanding of generics the literature is updated are posted in the form of as required. digital catalogs and PDF documents. Genecal Enables search as well as a trial calculation of generics (through links to external sites). Administrative notice library A bulletin board for posting of government notices regarding generics issued by such administrative bodies as the Ministry of Health, Labor and Welfare. MPS Team MPS Team activities Nichi-Iko established its MPS Team (medical services management support information provision team) in 2000. The MPS Team comprises MPS consultants certified by the Japan Association of Health Service Management Consultants and qualified personnel who have acquired our in-house MPS advisor certification. Its members pursue efforts to provide information to medical professionals beyond the confines of our own products. These undertakings encompass preparation of explanatory materials concerning not only product information but governmental information as well — primarily information regarding medical fees — and conducting briefing sessions. 8 Corporate Brochure 2012 Nichi-Iko Pharmaceutical Co., Ltd. Briefing sessions The activities of the MPS Team center on briefing sessions held to explain generic pharmaceuticals and distribute medical treatment administration information as well as to provide information compiled by the MPS Team in data format. The number of briefing sessions is trending upward, showing particularly dramatic increases in years in which medical fees are revised. Honeycomb MPS Plan We are promoting the “Honeycomb MPS Plan,” which encourages all our MRs to obtain either MPS consultant certification or our in-house MPS advisor qualification. We support our MRs’ activities to ensure their ability to offer added value, such as information on health service management and medical treatment administration. New DI page design We have redesigned our drug information search page (DI page) to provide a “panoramic view” on the screen and facilitate access to the information. The site allows visitors to search and view package inserts and shows the proper use as well as photos of our products. Public disclosure of line listing of side effects As the next step in our “Action Program to Promote Safe Use of Generic Drugs,” we post safety information (line listing of side effects and treatment results studies) on our product information search page. *Cases of side effects reported to the Pharmaceuticals and Medical Devices Agency (since 2004) are posted in accordance with the stipulations of the Pharmaceutical Affairs Law. (In principle, information is provided for ethical drugs for which Nichi-Iko Pharmaceutical Co., Ltd. has received manufacturing and marketing approval.) *Results for products on which post-marketing studies have been conducted are posted on the DI search page. 1,800 30,000 1,200 20,000 600 10,000 01 02 03 04 05 06 07 08 09 10 (Forecast) Nichi-Iko Pharmaceutical Co., Ltd. Corporate Brochure 2012 9 MoreResponsive Operating Systems A Structure That Quickly Respond to Market Demand Nichi-Iko secures an extensive range of production lines at five production sites in its endeavors to further increase the efficiency of its production. We are constantly looking for ways to improve our generic pharmaceuticals distribution systems, moreover, to speed up delivery and respond promptly to customer requests. We are also constructing an independent system to assist MRs assigned to branch offices throughout Japan in dispensing information. MR Support Systems We are constructing various systems to support the information provision activities of our MRs assigned to eight branch offices throughout the country. •Facsimile transmission of emergency safety information When important emergent information is received, this system immediately transmits the initial report on the information to medical experts who use our products. Production Network Nichi-Iko's production network consists of five plants as indicated in the map on the right. The resulting consolidation of drug formulation •Market support system “Nextstage” according to plant has augmented production efficiency and generated •Web conferencing system “JoinMeeting” new synergies. The company has also implemented production reforms Power egg •TV conferencing system “e-learning” •Information search engine “savvy” An information-sharing system for communications such as answers from the Customer Support Center •In-house intranet “POWER EGG” •In-house information provision to MRs via mobile devices Facsimile system to ensure rapid responsiveness to growth of the generics market. Establishment of Nichi-Iko Medical Practice Institute Co., Ltd. Joint research with the University of Tokyo On September 1, 2011, the Company Company profile Grasping the needs of medical professionals and pharmaceuticals users established Nichi-Iko Medical Practice is essential for “fostering and developing” generic drugs. We assign Institute Co., Ltd. (Nichi-Iko MPI). Nichi- researchers to the University of Tokyo’s Laboratory of Drug Informatics, Iko MPI is the Company’s first in-house Establishment: September 1, 2011 Graduate School of Pharmaceutical Sciences, where they conduct joint venture firm, founded by spinning off Location: 1-6-21 Sogawa, Toyama-shi, Toyama Prefecture, Japan 930-8583 research. Our goal is to construct a “fostering and developing” cycle the Company’s sales information unit that solves various problems that can arise among pharmaceutical and making it an independent group Representative: Tsuneo Kikuchi, representative director companies, medical professionals and medicine users. company. Nichi-Iko MPI will contribute Manufacturing Base Nichi-Iko Pharma Factory Co., Ltd. Yamagata Plant Namerikawa Dai-ni (second) Plant Company name: Nichi-Iko Medical Practice Institute Co., Ltd. (Nichi-Iko MPI) Major operations:Creation and sale of materials to provide information, sales support to the health care industry by providing (education and training as well as accompanying sales personnel high-level information on medical for business negotiations), support for lectures and study groups administration, supporting the Nichi- and dispatch of lecturers, consulting (human resource development, Iko Group’s sales strategy, and actively organizational management, etc.), and provision of information offering relevant information to medical through websites (Stu-GE, a website for health care workers institutions and distributors. concerning generic pharmaceuticals and medical administration) Namerikawa Dai-ichi (first) Plant East Japan Distribution Center Nichi-Iko Distribution Center Nichi-Iko Pharma Factory Co., Ltd. Saitama Plant Distribution System The core of our distribution system is the Nichi-Iko Distribution Center in Namerikawa City, Toyama Prefecture, which went into operation in 2003. Regional deliveries are made from two other Nichi-Iko Pharma Factory Co., Ltd. Aichi Plant strategically located centers, the East Japan Distribution Center in Kuki, Saitama Prefecture, and the West Japan Distribution Center in Kobe, Hyogo Prefecture. The Nichi-Iko Distribution West Japan Distribution Center Center operates three automated pallet warehouses with a capacity for shipping 1,200 packages to up to 400 locations per day. We make every effort to ensure supply stability by constantly upgrading our production and inventory systems to maintain optimal inventories based on voluminous supply data Theophylline tablets imported from overseas. and detailed supply plans and to assure our ability to respond flexibly to sudden fluctuations in demand. 10 Corporate Brochure 2012 Nichi-Iko Pharmaceutical Co., Ltd. Nichi-Iko Pharmaceutical Co., Ltd. Corporate Brochure 2012 11 Promise ultra-highQuality Our to State-of-the-Art Production Facilities with a Commitment to ultra-high quality Becoming the Most Valued Partner for Medical Care Professionals Nichi-Iko’s technical staff do their share to provide ultra-high quality generics by making full use of their abundant Generics manufacturers are required to follow the same GMP (Good Manufacturing Practice) standards stipulated in technological experience and expertise in pharmaceutical dosage form design through every stage, from development to ordinances promulgated by the Ministry of Health, Labor and Welfare as those applied to branded drug manufacturing. manufacturing. They are guided in constructing systems that ensure consistent production of excellent generics by the Nichi-Iko’s Quality Control Division, which now operates independently of the Manufacturing Division, ensures compliance concept, “Quality creation begins in the development stage.” We will continue to advance the automation, robotics and with the standards by performing rigorous product quality inspections involving various tests at each stage of the performance of our manufacturing facilities while pursuing risk and cost reductions in order to supply superior generics. production process, from receipt of ingredients and raw materials to completion of the final products. Production capacity enhancement Initiatives for quality systems Nichi-Iko Group Quality Policy We are constructing systems that ensure Nichi-Iko Pharma Aichi Plant Since 2010, the Company has worked to The Nichi-Iko Group promises not only to comply with laws and stable supply stability by improving (Injections and antibiotics) implement the Guidelines for pharmaceutical Quality regulations applicable to pharmaceuticals, but also to grasp the manufacturing performance through Systems as required by ICH-Q10. In accordance expectations of patients, pharmacists, doctors, wholesalers and facilities investment. Our plants in with the guiding principle “There is no single Namerikawa, Aichi, Saitama and Yamagata employee that has nothing to do with quality,” we pharmaceutical companies throughout the world, and to manufacture and market generic drugs that satisfy their expectations. In addition to observing the GMP and GQP for medicinal drugs, the conduct consolidated manufacturing by Nichi-Iko Pharma Yamagata Plant have united efforts so that each and every one of applying preparation-specific production. (Disinfectants and JP products) the employees understands the Nichi-Iko Group’s Pharmaceutical Quality System guidelines. On behalf of the Nichi-Iko quality policy, becomes aware of his or her duty, Group, I commit the Group to keeping these promises. and gains the trust of medical institutions. A number of products : as of December 2011 Nichi-Iko Pharma First, in May 2010, the Company announced the Saitama Plant (Value- Nichi-Iko Group Quality Policy shown to the right, added preparations, and the president declared that he himself would external preparations review all quality-related projects and allocate and eyedrops) managerial resources to these projects. Oral Medicine 534 (GE 409) We will implement without fail the plan-do-check- Injectable Drug 168 (GE 126) customer needs precisely, promote product design External Preparation 138 (GE 100) Total 840 (GE 635) act cycle (PDCA cycle) in which we identify Namerikawa First and and product improvement, check the quality of Second Plants (Internal products and services constantly, and pay particular medicines and granules) attention to continuous improvement, thus providing customers with high-quality products. Plans call for reallocation of managerial resources Nichi-Iko Group will strive to construct systems according to the ICH We have set quality targets for the items listed below, and I will personally review the results and check the degree of their achievement. 1In consideration of drug-related ethics and morals, ensure compliance with laws and regulations throughout the organization. 2Acquire a comprehensive grasp of users’ expectations, needs and concerns and reflect them in the improvement of existing products and development of new ones. 3Engage in centralized management of quality information from the drug development to the manufacturing and sales stages, and continuously implement both corrective and preventive action. 4Prior to selecting contracted manufacturers and drug substance suppliers, assure due diligence in auditing of their performance and their supply appropriateness and capabilities, and continue to monitor their status on an ongoing basis. 5Ensure access to quality-related technologies and information, and adopt an uncompromising attitude toward maintaining and improving quality. 6Review reports on quality assurance, and make appropriate decisions concerning such issues as investment of management resources. through the first management review in June 2012. Pentagon Building, Honeycomb Building (Left)The “Pentagon Building,” which went into operation in April 2010, has approximately three times the production capacity of the former plant. (Right) The “Honeycomb Building,” global development and quality control center was completed in October 2011. 12 Corporate Brochure 2012 Nichi-Iko Pharmaceutical Co., Ltd. Thus we will provide “ultra-high quality” generic pharmaceuticals further. May 1, 2010 President & Chief Executive Officer Yuichi Tamura Cooperation with controlled clinical trials Establishment of Active Pharma Co., Ltd. Controlled clinical trials were conducted on Amlodipine Determined to develop systems to facilitate centralized Tablets Nichi-Iko and Amlodipine OD Tablets Nichi- management of every process, from evaluation of drug Iko in 2008 and 2009, respectively. Carried out substances to manufacturing, as part of our efforts to by an independent institution, the trials compared realize “ultra-high quality,” we established Active Pharma the hypotensive effects on patients with essential Co., Ltd. in June 2009. A joint venture with Mitani Sangyo hypertension of our products with those of branded Co., Ltd., Active Pharma is a core manufacturer of active drugs. They confirmed that neither of our products pharmaceutical ingredients for medicinal drugs. Every was inferior to the brand-name drugs in terms of either process is now managed within our Group, assuring our hypotensive effect or safety. ability to supply “ultra-high quality” generic pharmaceuticals. Nichi-Iko Pharmaceutical Co., Ltd. Corporate Brochure 2012 13 Financial Section Operating Results for the Year ended November 30, 2011 During the current consolidated fiscal year, in addition to yen for an additional equity investment in Aprogen Inc., its Furthermore, in November 2011, the Company entered it hosted in order to help the victims of the disaster to the effects of the Great East Japan Earthquake and the affiliated company in South Korea, in order to energetically into a comprehensive agreement with sanofi-aventis to recover and reconstruct their communities. ensuing disaster at a nuclear power station, the Japanese promote development of biosimilars. The “Honeycomb jointly promote some of the generics whose manufacture economy continued to face difficulties as the appreciation Building,” global development and quality control center and sale its group has the right to approve. Thus it will As a result, during the current consolidated fiscal year, the of yen was driven by such factors as the instability of constructed using part of these funds, was completed in strive to spread generics mainly as drugs to treat such Company posted net sales of 77.74 billion yen, a 20.8% the European economy and the slowdown of the world October 2011 and started operation in November of the diseases as cancer, thrombosis, and diabetes--- major increase compared to the previous year. Consolidated economy, and its future outlook remained uncertain. same year. areas on which it focuses its managerial resources and in operating income and ordinary income were 7.492 which it claims the efficacy of its products. billion yen (up 5.6%) and 7.309 billion yen (up 6.2%), In the pharmaceutical industry, the use of generics With its listing on the Tokyo Stock Exchange, the continued to expand mainly among the dispensing Company was delisted from the Osaka and Nagoya Stock In September 2011, the Company established Nichi- term was 3.908 billion yen (up 1.1%). Thus the Company pharmacies though the pace of progress in the expansion Exchanges in December 2011 to concentrate the trading Iko Medical Practice Institute Co., Ltd., its wholly owned achieved record net sales and profits. of their use generally became slower than the Company of its shares in the Tokyo Stock Exchange and reduce subsidiary, to provide its wholesalers and medical had predicted. costs incurred by double listing. institutions with information on medical practice, and the By product item, sales of the oral prostaglandin E1 derivative Institute began operation immediately. Opaprosmon (5μg tablet), the anti-hyperlipidemic Mevan respectively. Consolidated net income for the current The Company obtained a listing on the First Section As one of its initiatives for the business alliance with the of the Tokyo Stock Exchange in December 2010, and sanofi-aventis Group, meanwhile, the Company took The Nichi-Iko Group’s operations suffered only minor Pranlukast (112.5mg capsule), B-Soften Lotion (0.3%) and subsequently, from February to March 2011, it raised a over the sale of Lasix , Eutensin , and Cerocral , long- direct damage from the Great East Japan Earthquake, and Ointment (0.3%) for moisturizing the skin and promoting total of 16.575 billion yen in funds by offering new shares listed original drugs whose manufacture and sale sanofi- in addition to providing support such as pharmaceuticals better circulation, and the sustained release calcium for public subscription and allotting to third parties shares aventis K.K. has the right to approve, and began their and contributions, the Company has implemented charity antagonist Corinael (CR tablets 10, 20, 40) were strong. newly issued as part of the over-allotment. In March 2011, sale in June 2011. programs through professional sports events and concerts ® ® ® (5μg/10mg tablets), the leukotriene receptor antagonist it used part of the funds thus raised to pay 1.705 billion Consolidated Financial Highlights Net Sales Operating Income (Millions of yen) 77,740 80,000 Ordinary Income (Millions of yen) (Millions of yen) (Millions of yen) 8,000 8,000 4,000 7,097 64,352 60,000 7,492 6,883 6,246 7,309 Net Assets/Total Assets 3,762 3,865 3,908 (Millions of yen) (Yen) 100,000 160 3,442 82,786 6,000 5,175 3,000 5,442 65,575 101.54 50,982 4,000 4,000 2,000 50,000 20,000 2,000 2,000 1,000 25,000 44,593 26,099 16,079 Corporate Brochure 2012 111.83 57,466 42,841 14 121.98 122.50 120 75,000 40,000 2008/11 Net Income Per Share 6,121 6,000 54,806 Net Income 2009/11 2010/11 2011/11 Nichi-Iko Pharmaceutical Co., Ltd. 2008/11 2009/11 2010/11 2011/11 2008/11 2009/11 2010/11 2011/11 2008/11 2009/11 2010/11 2011/11 2008/11 18,809 2009/11 2010/11 2011/11 80 40 2008/11 2009/11 2010/11 Nichi-Iko Pharmaceutical Co., Ltd. 2011/11 Corporate Brochure 2012 15 Consolidated Financial Statements Consolidated Balance Sheets As of November 30 (Thousands of yen) 2010 2011 (Thousands of yen) As of November 30 2010 2011 Assets Liabilities Current assets Current liabilities Cash and deposits Notes and accounts payable-trade 13,252,531 13,350,605 Short-term loans payable 12,447,000 5,417,111 1,512,722 2,359,344 365,199 495,224 Accounts payable-other 1,716,224 2,158,746 4,163,779 Accrued expenses 1,065,932 1,129,274 935,616 1,050,821 Income taxes payable 1,069,000 2,038,000 1,075,538 856,475 Deposits received 82,541 86,947 (416,000) (443,000) Provision for sales returns 48,000 60,000 39,589,032 50,547,859 Other 70,453 97,076 31,629,605 27,192,330 1,694,401 4,126,371 18,637,368 24,666,216 Short-term investment securities 666 1,666 Merchandise and finished goods 10,054,619 13,245,668 Work in process 3,175,713 2,879,860 Raw materials and supplies 4,431,109 Notes and accounts receivable-trade Deferred tax assets Other Allowance for doubtful accounts Current assets-total Current portion of long-term loans payable Lease obligations Current liabilities-total Noncurrent liabilities Noncurrent assets Property, plant and equipment Buildings and structures, net 9,167,550 11,384,576 Machinery, equipment and vehicles net 3,890,685 3,565,361 Tools, furniture and fixtures, net 272,068 980,918 Land 3,410,877 3,803,962 Lease assets, net 1,090,311 1,189,852 Construction in progress 976,177 122,739 Property, plant and equipment-total 18,807,670 21,047,411 Intangible assets 3,376,125 6,158,774 Lease obligations 1,188,691 1,278,954 Deferred tax liabilities 322,290 415,333 Deferred tax liabilities for land revaluation 291,251 291,251 2,663,900 2,786,489 – 50,251 4,051 19,840 7,846,310 11,000,894 39,475,915 38,193,225 Provision for retirement benefits Asset retirement obligations Other Noncurrent liabilities-total Total liabilities Goodwill 938,747 804,186 Lease assets 385,606 424,208 Other 2,323,803 3,961,365 Capital stock 5,270,208 13,557,728 Intangible assets-total 3,648,156 5,189,760 Capital surplus 4,051,245 12,339,572 16,960,184 19,670,809 (392,671) (1,197,786) 25,888,968 44,370,324 Investments and other assets Net assets Shareholders' equity Retained earnings 2,369,502 4,110,800 Treasury stock Long-term loans receivable 326,166 698,706 Shareholders' equity Deferred tax assets 604,815 877,269 Accumulated other comprehensive income Other 308,739 460,138 Valuation difference on available-for-sale securities Allowance for doubtful accounts (78,625) (145,625) Investments and other assets-total 3,530,598 6,001,290 Noncurrent assets-total 25,986,426 32,238,462 Total assets 65,575,458 82,786,322 Investment securities Amounts less than ten thousand yen have been rounded down. 16 Long-term loans payable Corporate Brochure 2012 Nichi-Iko Pharmaceutical Co., Ltd. (51,062) (38,864) Land revaluation increment 261,637 261,637 Total accumulated other comprehensive income 210,574 222,772 Total net assets 26,099,542 44,593,096 Total liabilities and net assets 65,575,458 82,786,322 Amounts less than ten thousand yen have been rounded down. Nichi-Iko Pharmaceutical Co., Ltd. Corporate Brochure 2012 17 Consolidated Financial Statements Consolidated Statements of Income (Thousands of yen) For year ended November 30 2010 Net sales 64,352,501 Cost of sales 36,949,887 Gross profit 27,402,614 Provision for sales returns 9,000 Gross profit-net 27,393,614 Selling, general and administrative expenses 20,296,075 Operating income 7,097,538 Non-operating income Interest income 5,424 Dividends income 16,788 Amortization of negative goodwill 124,210 Reimbursement for joint development cost 52,433 Compensation income – Sales commissions receivable – Other 186,720 Non-operating income 385,576 Non-operating expenses Interest expenses 231,767 Commission fee 121,859 Loss on sales of notes payable 33,475 Loss on sales of trade receivables 76,478 Stock issuance cost – Business alliance expenses 80,000 Other 55,736 Non-operating expenses 599,317 Ordinary income 6,883,796 Extraordinary income Gain on sales of property, plant and equipment 11,454 Reversal of allowance for doubtful accounts 3,537 Gain on revision of retirement benefit plan – Extraordinary income 14,992 Extraordinary loss Loss on disposal of property, plant and equipment 88,947 Impairment loss 378,460 Loss on revaluation of investment securities 48,013 Factory suspension expenses 498,696 Product voluntary recall cost – Loss on disaster – Other 13,255 Extraordinary loss 1,027,373 Income before income taxes 5,871,415 Income taxes-current 2,030,518 Income taxes-deferred (24,752) Income taxes 2,005,765 Income before minority interests – Net income 3,865,649 2011 77,740,645 46,423,717 31,316,927 12,000 31,304,927 23,812,878 7,492,048 13,771 23,830 18,630 47,810 71,956 51,384 134,182 361,566 188,042 34,947 – 86,772 100,517 – 133,706 543,987 7,309,627 3,392 – 25,853 29,245 132,168 – 101,914 – 229,525 233,780 55,741 753,130 6,585,742 2,975,604 (297,870) 2,677,733 3,908,009 3,908,009 Amounts less than ten thousand yen have been rounded down. Statements of comprehensive income Income before minority interests Income before minority interests Other comprehensive income Valuation difference on available-for-sale securities Total other comprehensive income Comprehensive income Comprehensive income attributable to Comprehensive income attributable to owners of the parent Comprehensive income attributable to minority interests (Thousands of yen) 2010 – – 2011 3,908,009 3,908,009 – – – 12,197 12,197 3,920,207 – – 3,920,207 – Per share information For year ended November 30 Basic net income per share (EPS) Diluted net income per share Cash dividends per share (yen) 2010 122.50 122.42 32.00 2011 101.54 101.53 32.00 Consolidated Statements of Changes in Net Assets (Thousands of yen) For year ended November 30 2010 Shareholders’ equity Capital stock: Balance at the end of previous period 3,064,257 Changes of items during the period Issuance of new shares 2,205,951 Total changes of items during the period 2,205,951 Balance at the end of current period 5,270,208 Capital surplus: Balance at the end of previous period 1,837,737 Changes of items during the period Disposal of treasury stock 7,557 Issuance of new shares 2,205,951 Total changes in items during the period 2,213,508 Balance at the end of current period 4,051,245 Retained earnings: Balance at the end of previous period 14,017,801 Changes of items during the period Dividends from surplus (925,456) Net income 3,865,649 Reversal of land revaluation increment 2,189 Total changes in items during the period 2,942,382 Balance at the end of current period 16,960,184 Treasury stock: Balance at the end of previous period (423,731) Changes of items during the period Purchase of treasury stock (1,982) Disposal of treasury stock 33,042 Total changes in items during the period 31,060 Balance at the end of current period (392,671) Total shareholders’ equity: Balance at the end of previous period 18,496,064 Changes of items during the period Issuance of new shares 4,411,903 Dividends from surplus (925,456) Net income 3,865,649 Reversal of land revaluation increment 2,189 Purchase of treasury stock (1,982) Disposal of treasury stock 40,600 Total changes in items during the period 7,392,903 Balance at the end of current period 25,888,968 Accumulated other comprehensive income Valuation difference on available-for-sale securities: Balance at the end of previous period 49,281 Changes of items during the period Net changes in items other than shareholders’ equity (100,344) Total changes in items during the period (100,344) Balance at the end of current period (51,062) Land revaluation increment: Balance at the end of previous period 263,826 Changes of items during the period Net changes in items other than shareholders’ equity (2,189) Total changes in items during the period (2,189) Balance at the end of current period 261,637 Total accumulated other comprehensive income Balance at the end of previous period 313,108 Changes of items during the period Net changes in items other than shareholders’ equity (102,533) Total changes in items during the period (102,533) Balance at the end of current period 210,574 Total net assets Balance at the end of previous period 18,809,173 Changes of items during the period Issuance of new shares 4,411,903 Dividends from surplus (925,456) Net income 3,865,649 Reversal of land revaluation increment 2,189 Purchase of treasury stock (1,982) Disposal of treasury stock 40,600 Net changes of items other than shareholders’ equity (102,533) Total changes of items during the period 7,290,369 Balance at the end of current period 26,099,542 2011 5,270,208 8,287,520 8,287,520 13,557,728 4,051,245 806 8,287,520 8,288,326 12,339,572 16,960,184 (1,197,383) 3,908,009 – 2,710,625 19,670,809 (392,671) (861,101) 55,986 (805,115) (1,197,786) 25,888,968 16,575,040 (1,197,383) 3,908,009 – (861,101) 56,792 18,481,356 44,370,324 (51,062) 12,197 12,197 (38,864) 261,637 – – 261,637 210,574 12,197 12,197 222,772 26,099,542 16,575,040 (1,197,383) 3,908,009 – (861,101) 56,792 12,197 18,493,553 44,593,096 Amounts less than ten thousand yen have been rounded down. 18 Corporate Brochure 2012 Nichi-Iko Pharmaceutical Co., Ltd. Nichi-Iko Pharmaceutical Co., Ltd. Corporate Brochure 2012 19 Consolidated Corporate Financial Statements Data Consolidated Statements of Cash Flows (Thousands of yen) For year ended November 30 2010 Cash flows from operating activities Income before income taxes 5,871,415 Depreciation and amortization 2,857,048 Impairment loss 378,460 Amortization of goodwill 189,511 Amortization of negative goodwill (124,210) Increase (decrease) in allowance for doubtful accounts (2,712) Increase (decrease) in provision for retirement benefits 86,222 Increase (decrease) in provision for sales returns 9,000 Interest and dividends income (22,212) Interest expenses 231,767 Loss (gain) on revaluation of investment securities 48,013 Loss (gain) on sales of property, plant and equipment (11,454) Loss (gain) on disposal of property, plant and equipment 88,947 Stock issuance cost – Decrease (increase) in notes and accounts receivable (4,225,753) Decrease (increase) in inventories (1,533,247) Increase (decrease) in notes and accounts payable 1,745,133 Other - net (155,914) Subtotal 5,430,016 Interest and dividend income received 22,237 Interest expenses paid (259,089) Income taxes paid (2,446,022) Net cash provided by (used in) operating activities 2,747,141 Cash flows from investing activities Payments into time deposits – Proceeds from withdrawal of time deposits 15,000 Proceeds from sales of short-term investment securities 666 Purchase of long-term investment securities (66,164) Purchase of property, plant and equipment (3,111,242) Proceeds from sales of property, plant and equipment 25,282 Purchase of intangible assets (1,229,197) Purchase of stocks of subsidiaries and affiliates (1,028,623) Payments of loans receivable (20,000) Collection of loans receivable 698 Other - net 4,034 Net cash used in investing activities (5,409,546) Cash flows from financing activities Increase (decrease) in short-term loans payable 1,022,000 Proceeds from long-term loans payable – Repayment of long-term loans payable (1,471,436) Proceeds from issuance of common stock 4,391,520 Purchase of treasury stock (1,982) Proceeds from sales of treasury stock – Proceeds from exercise of stock option 40,600 Repayments of finance lease obligations (230,776) Cash dividends paid (923,517) Net cash (used in) provided by financing activities 2,826,407 Effect of exchange rate change on cash and cash equivalents (9) Net increase in cash and cash equivalents 163,993 Cash and cash equivalents at beginning of year 1,022,823 Cash and cash equivalents at end of year 1,186,816 Corporate Data (as of November 30, 2011) 2011 Company name Nichi-Iko Pharmaceutical Co., Ltd. Establishment July 1965 6,585,742 4,201,366 – 153,191 (18,630) 94,000 122,589 12,000 (37,601) 188,042 101,914 (3,392) 132,168 100,517 (6,096,218) (2,627,865) 98,074 549,914 3,555,813 32,068 (176,507) (2,039,744) 1,371,629 Capital Stock 13,557.72 million yen Number of employees 792 (consolidated basis) (1,520,000) 1,600,084 666 (118,178) (4,437,876) 15,654 (2,902,238) (1,711,440) (434,700) 24,760 (21,606) (9,504,875) (7,029,888) 6,379,000 (2,749,729) 16,474,522 (861,101) 30,692 26,100 (428,147) (1,196,128) 10,645,318 (18) 2,512,054 1,186,816 3,698,871 Contents of businessManufacturing, sales, distribution, export and import of ethical drugs and quasi-drugs and related activities (Notes) 1.The number of employees excludes 272 part-time and fixed-term contract employees. Stock Listings Tokyo Stock Exchange, the first section Head Office 1-6-21 Sogawa, Toyama-shi, Toyama Prefecture, Japan 930-8583 Branch Offices Sapporo office, Sendai office, Kanto office, Tokyo offices 1 and 2, Tokai-Hokuriku office, Osaka office, Hiroshima office, Fukuoka office Production Sites Namerikawa Dai-ichi (first) Plant (Namerikawa-shi, Toyama Prefecture) Namerikawa Dai-ni (second) Plant (Namerikawa-shi, Toyama Prefecture) Nichi-Iko Pharma Factory Co., Ltd. Aichi Plant (Kasugai-shi, Aichi Prefecture) Nichi-Iko Pharma Factory Co., Ltd. Yamagata Plant (Tendo-shi, Yamagata Prefecture) Nichi-Iko Pharma Factory Co., Ltd. Saitama Plant (Saitama-shi, Saitama Prefecture) Development Center Development and quality control center (Namerikawa-shi, Toyama Prefecture) Distribution Centers Nichi-Iko Distribution Center (Namerikawa-shi, Toyama Prefecture) East Japan Distribution Center (Kuki-shi, Saitama Prefecture) West Japan Distribution Center (Kobe-shi, Hyogo Prefecture) Major Shareholders (as of November 30, 2011) Shareholder name No. of shares held (thousands) Percentage of total shares held (%) Tamura LLC 4,269 10.56 Hokuriku Bank, Ltd. 1,927 4.77 Sanofi-aventis K.K. 1,897 4.70 Japan Trustee Services Bank, Ltd. (Trust account) 1,414 3.50 The Master Trust Bank of Japan, Ltd. (Trust account) 1,388 3.43 Nipro Corporation 1,321 3.27 Japan Trustee Services Bank, Ltd. (Trust account 9) 1,211 3.00 Yuichi Tamura 1,038 2.57 GOLDMAN, SACHS & CO. REG 950 2.35 STATE STREET BANK AND TRUST COMPANY 505044 865 2.14 (Notes) 1.The percentage of total shares held is calculated excluding treasury shares (314,840 shares). 2.The percentage of total shares held is rounded off to two decimal places. 3.On December 19, 2011, Tamura LLC changed its trade name to TAMURA Co., Ltd. Directors and Corporate Auditors (as of February 28, 2012) President and CEO Yuichi Tamura Senior Managing Executive Officer and Director Toshinori Kongoji Senior Managing Executive Officer and Director Shuko Urayama Senior Managing Executive Officer and Director Kenji Akane Managing Executive Officer and Director Taizan Kawakami Managing Executive Officer and Director Eiichi Machida Director Statutory Corporate Auditor Shigeo Takagi Shigekatsu Kumada Corporate Auditor Hajime Imamura Corporate Auditor Hitoshi Hori Corporate Auditor Shinichiro Handa Shareholder information (as of November 30, 2011) Total number of shares authorized 93,500,000 Shares issued and outstanding 40,729,417 Number of shareholders 12,008 Equity Shareholders by Type of Shareholders Japanese Financial Institutions Japanese Individuals and Others ( 11,607 / 10,477 ) 27.5% ( 47 / 11,193 ) thousand shares thousand shares 25.7% Securities Firms 1.2% ( 34 / 505 thousand shares ) (Notes) 1.Among the directors, Shigeo Takagi is an external director. 2.Among the corporate auditors, Hajime Imamura, Hitoshi Hori and Shinichiro Handa are external auditors. Other companies 26.8% ( 201 / 10,901 thousand shares ) ( Foreign Institutions and Individuals 119 / 7,651 ) 18.8% thousand shares Amounts less than ten thousand yen have been rounded down. 20 Corporate Brochure 2012 Nichi-Iko Pharmaceutical Co., Ltd. Nichi-Iko Pharmaceutical Co., Ltd. Corporate Brochure 2012 21
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